FDA 510(k) clearances — page 61
clearances on record, most recent first.
Clearances — page 61
6,001–6,100 of 175,620- K240689 — Robin's Egg
- K241230 — Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
- K241942 — TriMed Bridge Plates
- K242186 — Neo Sculptor (OF-NEO001)
- K232938 — Traus SSG30 Surgical System
- K234050 — HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
- K234089 — DNA Appliance
- K240638 — Power Wheelchair (YH-E7007)
- K241201 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System
- K241335 — Eversense 365 Continuous Glucose Monitoring (CGM) System
- K241379 — Powered Wheelchair (NXN20-205, NXN20-205M)
- K241762 — OneMark
- K241771 — Liftendo; Liftendo 2.0
- K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
- K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
- K233399 — Microdacyn Wound Care Solution
- K234063 — T2Candida 1.1 Panel
- K240087 — RT Carbon ECG Leads
- K240176 — V-VITFREEZE and V-VITWARM
- K240188 — Vitruvian Liposaber
- K240232 — EK D3.3 and Ultra Wide Implants
- K240544 — Epitomee
- K240929 — Sleep Apnea Notification Feature (SANF)
- K240977 — DenQ Sub SLA Implant System
- K241722 — Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment
- K241875 — TheRay Collared and Collarless Femoral Stem
- K242441 — Revian Lyte (10011)
- DEN230081 — Hearing Aid Feature (HAF)
- K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System
- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
- K233732 — CoolSculpting Elite System
- K240168 — N7-S
- K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
- K240803 — Surgikor Fixation One, Abutment Blanks and Abutments
- K240880 — VitalFlow Set with Balance Biosurface
- K240942 — CINA-CSpine
- K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
- K241280 — Constellation (CON-001)
- K241432 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
- K241493 — Glidewell 3DP Denture Base Resin
- K241524 — Elucid PlaqueIQ
- K241582 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
- K241695 — Extremity All Suture System
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
- K242136 — Electric wheelchair (C001)
- K242401 — EXULT Knee Replacement System
- K232559 — C&B NFH Hybrid
- K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K240683 — Rx Knee System
- K241004 — Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
- K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
- K241161 — Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging
- K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135)
- K241380 — FETOLY-HEART
- K241438 — Signus Tetris St; Signus Tetris R St
- K241745 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
- K241954 — SonoBlock; SonoBlock II
- K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
- K240094 — LumiNE US; Lumi
- K240990 — Mobility Scooter
- K241214 — ProPel SG3 Surgical Gown
- K241609 — Tornier Humeral Reconstruction System (Tornier HRS)
- K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K240233 — Pitkar Spinal Pedicle Screw System
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
- K240791 — ADAS 3D
- K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
- K241678 — TENS & EMS Stimulator (MHD-1083)
- K241681 — Overjet Image Enhancement Assist
- K242042 — TriALTIS Spine System
- K242349 — FoLix
- K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
- K240486 — PM2 System and ECGuide Connector
- K231667 — Withings Sleep Rx
- K232543 — MSC SFM
- K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
- K233806 — T2 Plus
- K233900 — Nordica PV Cryo Mapping Catheter
- K233911 — VISULAS combi
- K233921 — Luvis Chair (LC700C)
- K233974 — Mucosal Impedance Measurement System
- K234035 — COSINE Spacer
- K234044 — ACS® LD FB Knee System
- K240411 — uAI Portal
- K240600 — SafeCross Vascular Introducer System (4001)
- K241164 — IB3D PL Spinal System
- K241415 — Orchid Safety Release Valve
- K241427 — Access Syphilis
- K241552 — MENTOR MemoryGel Enhance Single Use Gel Sizer
- K241579 — DD Hybridlayer (multicolored zirconia)
- K241672 — COPRO 3
- K241693 — FemChec Controlled Saline-Air Device (FCD-250)
- K241976 — nextaro® va, 15mm, 5µm
- K242415 — TMC Compression Implant System
- K231566 — ICX-Implant System
- K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030
- K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
- K233998 — TRAQinform IQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.